Guidance for Industry and Food and Drug Administration Staff; Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Surveillance and Detention Without Physical Examination of Surgeons' and/or Patient Examination Gloves." This guidance document provides information to FDA staff and industry about FDA's strategy for addressing further imports of surgeons' and patient examination gloves (medical gloves) from manufacturers/shippers whose medical gloves have failed to meet FDA's minimum acceptable quality criteria. The guidance and the strategy are intended to help assure that medical gloves imported to the United States meet FDA's minimum acceptable quality criteria and do not have defects that could compromise their effectiveness and pose a health hazard to healthcare professionals and patients who rely on medical gloves for protection from blood- and fluid-borne pathogens.